Miriam Silaschi

Transcatheter aortic valve implantation versus surgical aortic valve replacement: A propensity score analysis in patients at high surgical risk

OBJECTIVES Transcatheter aortic valve implantation (TAVI) has recently been advocated to decrease perioperative risk in high-risk patients. In this propensity-score analysis we compared outcomes after TAVI to those after surgical aortic valve replacement (AVR). METHODS From June 2009 through June 2010, 82 consecutive patients underwent TAVI via a transapical (n = 60) or transfemoral (n = 22) approach using the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, Calif). Mean patient age was 81.9 ± 5.2 years, 64.6% were women. Logistic EuroSCORE was 23.6% ± 1.4% and Society of Thoracic Surgeons score was 8.7% ± 1.3%. A group of 82 patients after surgical AVR was retrieved from our database, yielding a control group that was matched to the cases with respect to baseline demographics and typical risk factors. RESULTS Overall mortality did not differ significantly between TAVI and AVR groups at 30 days (7.3% vs 8.6%), 90 days (13.6% vs 11.1%), or 180 days (17.8% vs 16.9%; P = .889). Conversion to surgery was necessary in 2 (2.4%) TAVI cases. Perioperative stroke occurred in 2 (2.4%) cases per group. Pacemakers were implanted for new-onset heart block in 3.7% and 2.4% in the TAVI and AVR groups, respectively (P = 1.0). TAVI resulted in shorter operative times (P < .001), shorter ventilation times (P < .001), and shorter length of stay in the intensive care unit (P = .008). Duration of hospital stay, however, was not significantly different (P = .11). CONCLUSIONS In our experience, mortality rates are similar after both types of procedure. Patients receiving TAVI benefit from faster postoperative recovery. Until more clinical data become available, the optimal procedure has to be determined for each patient according to individual risk factors.

Predicting Risk in Transcatheter Aortic Valve Implantation: Comparative Analysis of EuroSCORE II and Established Risk Stratification Tools.

BACKGROUND The logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) II was developed to improve prediction of mortality in cardiac surgery. However, no specific tools are available for risk prediction in transcatheter aortic valve implantation (TAVI). The recently introduced EuroSCORE II was compared with established risk scores. PATIENTS AND METHODS We assessed 457 consecutive patients (80.5 ± 7.1 years, 52.3% female) undergoing TAVI. Preoperative risk evaluation included logEuroSCORE I, EuroSCORE II, Society of Thoracic Surgeons (STS), Ambler, and Parsonnet scores. Validity was assessed by receiver-operating characteristic (ROC) and area under the curve (AUC). RESULTS A 30-day mortality was 9.6% (44/457). Calculated scores were logEuroSCORE I 22.0%, confidence interval (CI) 21.0 to 24.6; EuroSCORE II 7.0%, CI 6.4 to 8.1; STS 7.9%, CI 7.7 to 9.5; Ambler score 6.9%, CI 5.7 to 7.0; and Parsonnet score 23.8%, CI 20.9 to 24.1. ROC analyses demonstrated no predictive value: logEuroSCORE I AUC 0.56, CI 0.47 to 0.65; EuroSCORE II AUC 0.54, CI 0.46 to 0.63; STS AUC 0.57, CI 0.49 to 0.66; Ambler AUC 0.52, CI 0.43 to 0.60; and Parsonnet AUC 0.51, CI 0.43 to 0.60. Accuracy and thresholds were measured on behalf of Youden index. Accuracy ranged between 44.2% (Parsonnet) and 66.3% (logEuroSCORE I). Thresholds were logEuroSCORE I 26%, EuroSCORE II 7%, STS 6%, Ambler 3%, and Parsonnet 19%. CONCLUSIONS No risk evaluation system provided acceptable predictive ability. Scores derived from conventional cardiac surgery failed in risk prediction for TAVI. Specific risk tools are required. Until available, estimation of risk has to rely on judgment of an interdisciplinary heart team regarding individual patient factors.

Transcatheter valve-in-valve implantation versus redo surgical aortic valve replacement in patients with failed aortic bioprostheses.

OBJECTIVES Transcatheter aortic valve-in-valve implantation (ViV) is a new treatment for failing bioprostheses (BP) in patients with high surgical risk. However, comparative data, using standard repeat surgical aortic valve replacement (redo-SAVR), are scarce. We compared outcomes after ViV with those after conventional redo-SAVR in two European centres with established interventional programmes. METHODS In-hospital databases were retrospectively screened for patients ≥60 years, treated for failing aortic BP. Cases of infective endocarditis or combined procedures were excluded. End-points were adjudicated according to the Valve Academic Research Consortium (VARC-2) criteria. RESULTS From 2002 to 2015, 130 patients were treated (ViV: n = 71, redo-SAVR: n = 59). Age and logistic EuroSCORE I scores were higher with ViV (78.6 ± 7.5 vs 72.9 ± 6.6 years, P < 0.01; 25.1 ± 18.9 vs 16.8 ± 9.3%, P < 0.01). The 30-day mortality rate was not significantly different (4.2 and 5.1%, respectively) (P = 1.0). Device success was achieved in 52.1% (ViV) and 91.5% (P < 0.01). No stroke was observed after ViV but in 3.4% after redo-SAVR (P = 0.2). Intensive care stay was longer after redo-SAVR (3.4 ± 2.9 vs 2.0 ± 1.8 days, P < 0.01). Mean transvalvular gradients were higher post-ViV (19.7 ± 7.7 vs12.2 ± 5.7 mmHg, P < 0.01), whereas the rate of permanent pacemaker implantation was lower (9.9 vs 25.4%, P < 0.01). Survival rates at 90 and180 days were 94.2 and 92.3% vs 92.8 and 92.8% (P = 0.87), respectively. CONCLUSIONS Despite a higher risk profile in the ViV group, early mortality rates were not different compared with those of surgery. Although ViV resulted in elevated transvalvular gradients and therefore a lower rate of device success, mortality rates were similar to those with redo-SAVR. At present, both techniques serve as complementary approaches, and allow individualized patient care with excellent outcomes.

Is Mitral Valve Repair Superior to Mitral Valve Replacement in Elderly Patients? Comparison of Short‐ and Long‐Term Outcomes in a Propensity‐Matched Cohort

Background Because of demographic changes, a growing number of elderly patients present with mitral valve (MV) disease. Although mitral valve repair (MV‐repair) is the “gold standard” treatment for MV disease, in elderly patients, there is controversy about whether MV‐repair is superior to mitral valve replacement. We reviewed results after MV surgery in elderly patients treated over the past 20 years. Methods and Results Our in‐hospital database was explored for patients who underwent MV surgery between 1994 and 2015. Survival data, obtained from the National Health Service central register, were complete for all patients. Of 1776 patients with MV disease, 341 were aged ≥75 years. Patients with repeat cardiac surgery, endocarditis, and concomitant aortic valve replacement were excluded. This yielded 221 MV‐repair and 120 mitral valve replacement patients. Concomitant procedures included coronary artery bypass grafting in 135 patients (39.6%) and tricuspid valve surgery in 50 patients (14.7%). Thirty‐day mortality was 5.4% (MV‐repair) versus 9.2% (mitral valve replacement, P=0.26). Overall 1‐ and 5‐year survival was 90.7%, 74.2% versus 81.3%, 61.0% (P<0.01). Median survival after MV‐repair was 7.8 years, close to 8.5 years (95% CI: 8.2–9.4) in the age‐matched UK population (ratio 0.9). Rate of re‐operation for MV‐dysfunction was 2.3% versus 2.5% (mitral valve replacement, P=1.0). After propensity matching, patients after MV‐repair still had improved survival at 1, 2, and 5 years (93.4%, 91.6%, 76.9% versus 77.2%, 75.2%, 58.7%, P=0.03). Conclusions Excellent outcomes can be achieved after MV surgery in elderly patients. Long‐term survival is superior after MV‐repair and the re‐operation rate is low. MV‐repair should be the preferred surgical approach in elderly patients.

Dynamic transcatheter mitral valve repair: a new concept to treat functional mitral regurgitation using an adjustable spacer

We report the first-in-man implantation of the Mitra-Spacer. The device was implanted transapically. FMR was reduced to moderate. At two months, while in NYHA Class II, LVEF had improved, but FMR increased and 2 mL was added, reducing FMR to mild. Despite anticoagulation, thrombi developed around the device and the valve was replaced at eight months. The Mitra-Spacer successfully bridged this patient to surgery after LVEF had recovered.

Trends in Surgical Aortic Valve Replacement in More Than 3,000 Consecutive Cases in the Era of Transcatheter Aortic Valve Implantations

Objectives Biological prostheses for surgical aortic valve replacement (sAVR) are increasingly being considered in patients < 60 years of age. Likely, preserving the option of performing a transcatheter valve-in-valve (ViV) procedure in cases of structural valve deterioration has contributed to this development. We assessed the use pattern in sAVR over an 11-year period. Methods From 2002 through 2012, a total of 3,172 patients underwent sAVR at our center. Results Mean age was 70.4 ± 10.6 years and mortality was 1.9%. From 2002 to 2012, mean manufacturer given valve size increased from 22.8 ± 1.7 to 23.9 ± 2.0 mm (p < 0.001). Mean true internal diameter and effective orifice area increased from 19.6 to 20.3 mm (p = 0.027) and 1.41 to 1.56 cm(2) (p < 0.001), respectively. Use of mechanical valves decreased from 10.9 to 1.8% (p < 0.001), and patients were younger in 2012 than in 2002 (52.8 ± 16.5 vs. 41.0 ± 14.3 years; p = 0.028). Conclusion Profound change of use pattern in sAVR was observed as indication for biological prostheses became more liberal. Larger prostheses were implanted during the observational period. Especially in younger patients, optimal sizing is essential to preserve the option for subsequent ViV procedures.

The JUPITER registry: One‐year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation

We present 1‐year outcomes of the post‐market registry of a next‐generation transcatheter heart valve used for aortic regurgitation (AR).

Complicated infective aortic endocarditis: comparison of different surgical strategies

OBJECTIVES The choice of substitute during aortic valve replacement for infective endocarditis (IE) is still widely debated. We retrospectively reviewed all patients operated for aortic IE and compared groups according to the complexity of IE and substitutes implanted. METHODS From 2000 to 2015, 187 patients were treated using stentless bioprostheses (SBP) as root replacement (n = 30), mechanical prostheses (MP, n = 45) or stented bioprostheses (SP, n = 112) (mean follow-up 4.6 years, survival data 100% complete). RESULTS MP patients were younger (42.5 ± 10.7 vs 57.2 ± 16.9 years [SBP], 59.1 ± 14.1 years [SP], P < 0.01), but rates of intravenous drug use and chronic dialysis were not different. SBP patients more often had root involvement (83.3% vs 33.3% [MP], 25.9% [SP], P < 0.01) and prosthetic valve endocarditis (53.3% vs 6.7% [MP], 12.5% [SP], P < 0.01). In-hospital complications and length of stay were not different. Thirty-day mortality was 13.3% [SBP], 6.7% [MP] and 12.5% [SP] (P = 0.53). Five-year survival tended to be superior in SBP (83.3% vs 77.6% [MP], 67.1% [SP], P = 0.09). In patients with complicated IE (root involvement or prosthetic valve endocarditis, n = 77), SBP had superior long-term survival (86.9% vs 81.3% [MP], 57.2% [SP], PSBP/MP  = 0.07, PSBP/SP = 0.05). No early reinfection (<90 days) occurred in SBP vs 4.4% [MP] and 7.1% [SP] (P = 0.29). Reoperation for late reinfection occurred in 6.7% [SBP] vs 11.1% [MP] and 12.5% [SP] (P = 0.65). Prosthesis failure occurred in 3.3% [SBP] and 1.8% [SP] (P = 0.52). CONCLUSIONS Use of SBP provides favourable outcomes in patients with IE with low rates of reinfection and valve deterioration. It seems to be an optimal device in patients with complex IE.

Are intraoperative flow measurements sufficient to allay concerns about flow capacity of skeletonized internal thoracic arteries

We read with great interest the recently published meta-analysis by Sá et al. in this journal [1]. The authors analysed available data on the effects of skeletonized and pedicled internal thoracic arteries (ITAs) on intraoperative flow capacity. They evaluated data of 8 studies comprising 907 grafts and concluded that skeletonized ITA conduits are superior to pedicled ITA conduits. Moreover they observed advantages of skeletonized ITA conduits in females, patients with advanced age and diabetes. Although we share the opinion that skeletonized ITA conduits are advantageous in numerous ways and should be used routinely, particularly in patients undergoing arterial coronary artery bypass grafting (CABG) using bilateral ITAs, we do not think that the data provided in this meta-analysis are sufficient to remove all concerns about flow in skeletonized conduits raised by surgeons over recent years. Corresponding to the findings of Sa et al., we published previously that skeletonized ITAs provide higher free flows during surgery, with maximum mean flows after papaverine of 197.2 ± 66.6 ml/min and thus significantly higher compared with pedicled ITA conduits (147.1 ± 70.5 ml/min) [2]. One may feel that, given the relatively low flow demand measured in left ITA to left anterior descending (LAD) grafts of between 30 and 60 ml/min, these high flow capacities do not provide any clinical advantage for patients. But keeping in mind that ITAs are increasingly used in a sequential fashion and complete arterial revascularization is also performed using T-grafts, in which total coronary flow is dependent on the flow provided by a single ITA, optimization of ITA flow is crucial to achieve excellent outcomes under these circumstances. Nevertheless, some surgeons do not only fear acute vasoconstriction of skeletonized ITA grafts during surgery, but also are concerned that postoperative graft physiology is affected by removing the pedicle from the ITA graft. For this reason, we also would like to make the authors aware of our previously published intravascular flow measurements in ITA grafts used for T grafts with bilateral ITAs or left ITA and radial artery grafts at 3 and 6 months post surgery. Results of these investigations showed maximum flows in skeletonized left ITAs with up to 136.34 ± 53.43 ml/min, with a coronary flow reserve comparable with single ITA grafts to the LAD [3]. In addition, we were able to demonstrate that left ITA flow in these T grafts was directly affected by the amount of native coronary artery disease, with their flow being highest in patients with occlusions in two main coronary territories (170–240 ml/min) [4]. These findings of normal bypass physiology in skeletonized ITA grafts in the mid-term course post CABG surgery should be sufficient to remove the last concerns about inferior long-term results in these grafts. For us, who have been performing CABG using skeletonized grafts now for nearly 20 years, it is quite surprising to note that there are still concerns about the reliability of these excellent conduits, which have revolutionized the way complete arterial revascularization can be provided to patients with coronary artery disease.

Transcatheter aortic valve implantation utilizing a non-occlusive balloon for predilatation

BACKGROUND Balloon aortic valvuloplasty (BAV) is routinely performed preceding transcatheter aortic valve implantation (TAVI). Among risks inherent in BAV is low cardiac output due to rapid ventricular pacing (RVP), especially in patients with severely impaired left ventricular function. We herein report early experience utilizing a non-occlusive balloon for BAV (TrueFlow™, BARD, Peripheral Vascular, Tempe, AZ, US), which does not require RVP. METHODS Between 11/2016 and 10/2017, 27 consecutive patients received TAVI using a non-occlusive balloon valvuloplasty catheter for predilatation and a self-expandable transcatheter heart valve (77.8% female, 81.7 ± 6.6 years, logEuroSCORE I 15.8 ± 10.3%, STS Prom Score 2.5 ± 0.5%). Hemodynamic measurements and acute outcome data were analyzed according to updated Valve Academic Research Consortium definitions. RESULTS Procedure time, fluoroscopy time and amount of contrast agent were 74.5 ± 17.4 min, 16.7 ± 6.9 min and 156.9 ± 92.7 ml. Device success and early combined safety were 100% and 92.6% (25/27). Effective BAV without RVP after the first inflation was achieved in 92.6% of the patients (25/27). Continuous recording of hemodynamics documented no relevant systemic pressure drop during BAV. Postdilatation with a regular balloon was required in 10/27 patients. No death was observed during 30-day follow-up. Resultant mean transvalvular gradient was 6.0 ± 3.5 mm Hg. In one patient a moderate paravalvular leakage was seen. CONCLUSIONS In this series of TAVI utilizing a novel non-occlusive balloon, safety and efficacy were demonstrated. Adequate predilatation was achieved in all cases without need for RVP and with stable hemodynamics. These results will have to be confirmed in larger patient cohorts.